510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Rad-Source Technologies, Inc.

Buford, GA, US

RAD SOURCE TECHNOLOGIES, INC. appears in FDA device records in Buford, GA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Rad-Source Technologies, Inc. in 2009.

Clearances by year, as a table
510(k) clearance decisions for Rad-Source Technologies, Inc., by decision year
YearClearances
20091
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K082921RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400MOTSubstantially Equivalent

Registered establishments

FDA registered establishments for Rad-Source Technologies, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30024590903002459090RAD SOURCE TECHNOLOGIES, INC.4907 Golden Parkway Suite 400, Buford, GA 30518 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0745-04RAD SOURCE RS 3000 Blood Irradiator Three Bag OptionThe firm completed a cooling system retrofit to preclude overheating and failure.Terminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain